The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Pediatric Myopia Progression

Oupushifang Pharmaceutical Technology Co., Ltd.

Status and phase: Enrolling; Phase 3

Conditions: Myopia; Myopia Progression

Treatments: Drug: Atropine sulfate eye drops 0.02%; Drug: Placebo eye drops; Drug: Atropine sulfate eye drops 0.01%

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06708156

CTR20240786 (Registry Identifier)

Details and patient eligibility

About

The clinical trial aims to test the effectiveness and safety of two low-dose atropine sulfate eye drops for delaying myopia progression in children and adolescents.

Primary Objective: evaluate the effectiveness of 0.01% and 0.02% atropine sulfate eye drops for 96 weeks compared to placebo in delaying myopia progression in children and adolescents. Secondary Objective: evaluate the safety of two low-concentration atropine sulfate eye drops (0.01%/0.02%) in delaying myopia progression in children and adolescents.

Exploratory Objective:

1. the efficacy and safety of two low-concentration atropine sulfate eye drops (0.01%/0.02%) for 144 weeks.
2. evaluate the rebound effect of two low-concentration atropine sulfate eye drops (0.01%/0.02%) after discontinuation.

Enrollment: 606 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The legal guardian of the subject voluntarily signed the written informed consent, and the subject over 8 years is required to sign the written informed consent voluntarily.
2. Patients with myopia aged 6 to 12 years, including cut-offs.
3. The equivalent spherical refraction ranges from -1.00 D to -4.00 D (automatic optometry under a cycloplegia condition) in both myopia eyes at inclusion screening.
4. The astigmatism of both eyes was ≤ 1.50 D under a cycloplegia condition at inclusion screening.
5. The antimetropia (measured by equivalent spherical refraction) is < 2.00 D at inclusion screening.
6. Able to comply with study requirements, attend all study visits (including telephone visits), and be willing to receive random grouping of atropine treatment or placebo.

Exclusion criteria

1. Allergic to this product or its excipients.
2. Suffering from eye diseases that may affect vision (e.g. lens diseases such as cataracts, glaucoma, fundus macular disease, keratopathy, uveitis, retinal detachment, severe vitreous opacity, etc., manifest strabismus, nystagmus, ocular acute inflammatory disease), history of recurrent chronic ocular inflammation, or any other ocular pathology (e.g., angular stenosis, shallow anterior chamber).
3. Intraocular pressure of either eye is > 21 mmHg or <10 mmHg at screening.
4. Use of low-concentration (0.05% and below) atropine sulfate eye drops (including various in-hospital preparations, except for test drugs) and orthokeratology lenses (OK lenses) within 6 months before the screening.
5. Use of other myopia control methods such as instruments (multifocal glasses, progressive multifocal glasses, etc.), medications (the use of cycloplegic agents for examinations such as optometry is allowed), and others (including traditional Chinese medicine, auricular acupuncture, massage, accommodative flippers, red light therapy instrument, etc.) within 3 months before screening.
6. Those who have participated in other clinical trials and received drug or medical device interventions within 3 months before screening.
7. Systemic or topical use of drugs that affect the efficacy evaluation, such as anticholinergics: atropine, pirenzepine, etc., and cholinomimetics: pilocarpine, etc. within 1 week before screening.
8. Combined with severe immune system disease, central nervous system disease, Down syndrome, asthma, cardiopulmonary insufficiency, liver and kidney dysfunction, etc.
9. Surgical intervention (ocular or systemic) within 6 months before screening, or planned surgery during the study.
10. Heart rate sustained (more than 10 minutes) greater than 120 beats/min at screening (after 10 minutes of rest if the ECG shows a heart rate greater than 120 beats per minute, the ECG should be retested 10 minutes later. If the retest result below 120 beats/min, the screening is successful; If the retest result is still >120 beats/min, screening failed).
11. Need for ocular use or systemic oral corticosteroids during the study. Intranasal, inhaled, topical cutaneous, intra-articular, perianal steroids, and short-term oral steroids (i.e., continuous use for < 2 weeks).
12. Other conditions that are considered unsuitable by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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606 participants in 3 patient groups, including a placebo group

Experimental group (0.01% atropine sulfate eye drops)

Active Comparator group

Description:

1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.

Treatment:

Drug: Atropine sulfate eye drops 0.01%

Experimental group (0.02% atropine sulfate eye drops)

Active Comparator group

Description:

1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.

Treatment:

Drug: Atropine sulfate eye drops 0.02%

Control group (placebo eye drops)

Placebo Comparator group

Description:

1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.

Treatment:

Drug: Placebo eye drops